To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries.

A Study to Assess the Acute Technical Success of Aorfix™ Stent Grafts in the Treatment of Abdominal Aortic and Aorto-Iliac Aneurysm Where a Significant Degree of Vessel Angulation Exists at the Neck of the Aneurysm

A prospective, open label, single-arm (non-randomized) multi-center, international clinical device investigation to collect safety and performance data concerning the Aorfix™ Stent Graft System in the treatment of abdominal aortic aneurysm and aorto-iliac aneurysm where a significant degree of vessel angulation exists

Device: Aorfix™ Stent Grafts (AAA endovascular procedure)

Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System

Other Name: Aorfix™

Detailed Description:

The Aorfix™ Stent Graft is currently a CE-marked product indicated for AAA where the angle of the aneurysm is <65o. The objective of this study is to evaluate the safety and performance of the bifurcated Aorfix™ Stent Graft in the treatment of infrarenal abdominal aortic aneurysms and aorto-iliac aneurysms, in infrarenal necks angulated > 60o (between 60 to 90 degrees) as measured by 3-dimensional reconstruction in order to widen the indication.

The investigation is a prospective open label, single arm, multi-centre clinical study. The study group will consist of 25 evaluable participants. In order to account for patients lost to follow up (estimated at approximately 20%) up to 30 patients will be enrolled in the study.

Eligibility

Ages Eligible for Study:

19 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of abdominal aortic aneurysm 50 mm or larger in diameter, 40 mm or larger in diameter if symptomatic (i.e. pain, embolisation), or documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery(ies), or any saccular aneurysm.

Infrarenal neck with a minimum length of 15 mm and a neck angulation between 60° and 90°, as assessed in 3 dimensions.

The iliac artery diameter must be of appropriate diameter (1 mm smaller than the device diameter), with an appropriate distal landing length. The tortuosity of the common or external iliac arteries or femoral arteries must be low to medium (refer to operations manual).

Patient provides written informed consent.

Patients >18 years who are suitable for endovascular repair.

Patient fit for endovascular surgery, with a diameter at the access sites of 7mm or larger bilaterally.

Patient has a life expectancy longer than the duration of the study.

Exclusion Criteria:

Patient has a ruptured aneurysm.

Patient has insufficient length of proximal aneurysm neck (<15mm from aneurysm to lowest renal artery and <20 mm from the aneurysm to the SMA).

Patient has known allergy to graft materials, Nitinol, or contrast media.

Patient's where imaging is problematic; an example is an obese patient.

Patient has co-morbidities that deny vascular access, including small / tortuous access vessels.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442065